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Completed

NCT Number: NCT03736733

Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.

The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.

Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

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Key information

Conditions

Fibromyalgia Behavior Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Physical Activity Rheumatic Diseases Sedentary Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient lived in t Loire (42) or Haute-Loire (43)
  • Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
  • French writing and speaking
  • Sedentary or low level of activity (less than 2 hours of regular physical activity per week at the time of inclusion)
  • Signature of informed consent

Exclusion criteria

  • Cardiac or respiratory diseases that contraindicate the practice of physical activity
  • Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
  • Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason

Treatment and study plan

Physical activity program

Other

Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.

Advice and recommendations of physical activity at home

Other

Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).

Primary outcomes

  1. Assessment of the impact of a 3-month program

    Time frame: at 3 months

    Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).

Secondary outcomes

  1. fatigue

    Time frame: at 3 months

    assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7.

    Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5

  2. Quality of sleep

    Time frame: at 3 months

    assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score.

    The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3.

    In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.

  3. Anxiety and Depression

    Time frame: at 3 months

    assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.

  4. pain catastrophizing

    Time frame: at 3 months

    assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time

  5. pain evaluation

    Time frame: at 3 months

    assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)

  6. muscle power

    Time frame: at 3 months

    evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.

  7. muscular endurance

    Time frame: at 3 months

    evaluated by dynamometry on a stress platform (arms and legs).

  8. gas exchange measurement

    Time frame: at 3 months

    evaluated during a stress test

  9. quantification of physical activity in meter-h/week

    Time frame: at 3 months

    evaluated by the APAQ : Adult Physical Activity Questionnaire

  10. sedentary times in hours/day

    Time frame: at 3 months

    evaluated by the APAQ : Adult Physical Activity Questionnaire

  11. daily energy expenditure

    Time frame: at 3 months

    evaluated by actimetry

  12. time of physical activity

    Time frame: at 3 months

    evaluated by actimetry

  13. physical inactivity

    Time frame: at 3 months

    evaluated by actimetry

  14. patient adherence

    Time frame: at 3, 6 and 12 months

    number of sessions performed

  15. Direct medical costs

    Time frame: at 3, 6 and 12 months

    consultations, examinations, hospitalizations in euros

  16. Direct non-medical costs

    Time frame: at 3, 6 and 12 months

    transport

  17. Cost of lost productivity

    Time frame: at 3, 6 and 12 months

    time not worked

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.

Acronym: FIMOUV 1

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Nov 9, 2018
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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